Actively Recruiting
Evaluate the Efficacy and Safety of FB825 in Adult With Allergic Asthma
Led by Oneness Biotech Co., Ltd. · Updated on 2026-01-12
100
Participants Needed
13
Research Sites
331 weeks
Total Duration
On this page
Sponsors
O
Oneness Biotech Co., Ltd.
Lead Sponsor
M
Microbio Shanghai Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a randomized, placebo-controlled and double-blind study to evaluate the efficacy and safety of FB825 in adult patients with moderate-to-severe allergic asthma.
CONDITIONS
Official Title
Evaluate the Efficacy and Safety of FB825 in Adult With Allergic Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years
- Diagnosed with moderate-to-severe allergic asthma for at least 12 months
- Documented reversibility in lung function or airway hyperresponsiveness within the past 24 months
- Pre-bronchodilator lung function (FEV1) between 40% and 80% predicted within 2 months prior to randomization
- On stable medium- or high-dose inhaled corticosteroid plus long-acting beta2-agonist (ICS/LABA) therapy for at least 3 months prior to screening, with stable dose for at least 30 days
- History of at least one asthma exacerbation in the past 12 months
- Total serum IgE of 125 IU/mL or higher at screening
- Positive skin prick test or environmental allergen-specific IgE above normal range
- Uncontrolled asthma during screening and randomization defined as Asthma Control Questionnaire (ACQ-5) score of 1.5 or higher
- Completed treatment for any recent respiratory tract infection at least 4 weeks before screening
- Female subjects of childbearing potential must use two forms of birth control, including a barrier method, throughout the study and 120 days after last dose
- Body weight of at least 40 kg at screening
- Normal or non-significant abnormal electrocardiogram (ECG)
- Able to provide written informed consent and comply with study requirements
You will not qualify if you...
- Asthma exacerbation or systemic steroid treatment within 30 days prior to randomization
- More than 20% change in lung function between screening and randomization
- Pregnant or lactating females
- Positive HIV test or taking antiretroviral medications
- Active Hepatitis B or C infection
- Active lung diseases other than allergic asthma
- Use of experimental drugs within 30 days or 5 half-lives before screening
- Treatment with monoclonal antibodies (IL-4, IL-5, IL-13, IL-15) within 6 months prior to screening
- Treatment with anti-IgE antibody within 6 months or 5 half-lives prior to screening
- History of alcohol or drug abuse affecting participation
- Medical conditions compromising study conduct or patient safety
- Severe liver or kidney disease as defined by lab criteria
- Immunosuppression or immunodeficiency
- Active or past tuberculosis infection
- History of malignancy within 5 years except certain skin and cervical cancers
- Current smoker with more than 10 pack-years
- High risk of parasitic infection with evidence of infection
- Recent live or COVID-19 vaccination within specified timeframes
- History of significant arrhythmias or respiratory failure requiring ICU admission
- History of anaphylaxis to biologic therapies
- Major surgery within 8 weeks prior to screening
- Comorbid diseases interfering with study
- Use of non-selective beta blockers or recent dose changes of selective beta-1 blockers
- Bronchial thermoplasty within 3 years or planned during study
- Active autoimmune diseases or high risk for such diseases
- Use of prohibited Traditional Chinese Medications within 3 months
- Poorly controlled aggravating conditions like gastroesophageal reflux disease
- Adrenal insufficiency or long-term systemic corticosteroid use
- Recent positive SARS-CoV-2 test within 3 months prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Kaohsiung Chang Gung Medical Foundation
Kaohsiung City, Taiwan
Actively Recruiting
2
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
3
Far Eastern Memorial Hospital
New Taipei City, Taiwan
Actively Recruiting
4
China Medical University Hospital
Taichung, Taiwan
Actively Recruiting
5
Taichung Venterans General Hospital
Taichung, Taiwan
Actively Recruiting
6
National Cheng Kung University Hospital
Tainan, Taiwan
Actively Recruiting
7
Linkou Chang Gung Memorial Hospital
Taipei, Taiwan
Actively Recruiting
8
MacKay Memorial Hospital
Taipei, Taiwan
Actively Recruiting
9
Ministry of Health and Welfare Shuang-Ho Hospital
Taipei, Taiwan
Actively Recruiting
10
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
11
Taipei Medical University Hospital
Taipei, Taiwan
Actively Recruiting
12
Taipei Municipal Wanfang Hospital
Taipei, Taiwan
Actively Recruiting
13
Taipei Veterans General Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
J
June Kuo
CONTACT
P
Pei-Jin Ho
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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